Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4115
Predicate | Object |
---|---|
rdf:type | |
rdfs:label |
Reno-Dip (Injection, Solution)
|
dailymed-instance:dosage |
Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to
administration whenever solution and container
permit. Reno-DIP (Diatrizoate Meglumine Injection USP
30%) should be at body temperature when
administered and may need to be warmed before use.<br/>Drip Infusion Pyelography: While preparation of the patient is not essential for
drip infusion pyelography, it is advocated by some
investigators. If desired, adults and older children
may be given a laxative the night before the
examination and a low residue diet the day before, to
clear the gastrointestinal tract. Clinicians who feel
that partial dehydration enhances radiographic
contrast recommend a low liquid intake for 12 hours
prior to the procedure; however, adequate hydration
has improved the quality of films for other
investigators. Preparatory partial dehydration is not
recommended in infants, young children, the elderly,
or azotemic patients (especially those with polyuria,
oliguria, diabetes, advanced vascular disease, or
preexisting dehydration). The undesirable
dehydration in these patients may be accentuated by
the osmotic diuretic action of the medium. In uremic patients partial dehydration is not
necessary and maintenance of adequate fluid intake
is particularly desirable. Cleansing enemas are not recommended, since they
may increase residual gas in the bowel. The recommended dose is 2 mL per pound of body
weight. The preparation is given by continuous
intravenous infusion, over a period of 8 minutes or
longer , through a needle with a
large bore, usually a 17- or 18-gauge needle. In older
patients and in patients with known or suspected
cardiac decompensation, a slower rate of infusion is
probably wise. If nausea or flushing occurs during administration,
the infusion should be slowed or briefly interrupted. Films are taken before the onset of the infusion and
at the desired intervals following its completion.
When renal function is normal, a nephrogram may be
taken as soon as the infusion is completed, and films
of the collecting system at 10 and 20 minutes
thereafter. Voiding cystourethrograms are usually
optimal at 20 minutes after the infusion is completed.
In hypertensive patients, early minute sequence films
may be taken during the course of infusion, in
addition to subsequent pyelograms. In patients with
renal dysfunction, optimal visualization is usually
delayed, and the late films are taken as indicated. The nephrogram obtained by the drip infusion
procedure may be dense enough to obscure the
pelvocalyceal system in some cases. The presence of
gas in the bowel may hamper early visualization of
the renal collecting system. Tomographic���cuts���may
help to overcome such difficulties. Nephrotomography may begin when the infusion is
completed. The sustained contrast achieved by the
drip infusion technique eliminates the need for
precise timing and teamwork that is necessary with
ordinary nephrotomography. Thus, if nephrograms
taken after infusion of the medium suggest the need
for sectional films, or if preselected tomographic���cuts���are not sufficient, additional tomograms may
be obtained at once, and without repetition of
dosage.<br/>Computed Tomography:<br/>Brain Scanning: The suggested dose is 2 mL per pound of body
weight by intravenous drip over a period of eight
minutes or longer; scanning may be performed
during administration and/or immediately afterwards.<br/>Body Scanning: The usual adult dose is 300 mL administered by
intravenous infusion over a period of approximately
20 minutes; 150 mL may be infused immediately
prior to scanning, and the balance during scanning.
Scanning may also be performed immediately
following completion of infusion of the entire dose. Gastrografin (Diatrizoate Meglumine and Diatrizoate
Sodium Solution USP), an oral radiopaque contrast
agent, may be useful as an adjunct to the procedure.<br/>Patient Preparation: No special patient preparation is required for contrast
enhancement of CT brain scanning or body scanning.
However, it is advisable to insure that patients are
well hydrated prior to examination.<br/>Lower Extremity Venography: Appropriate premedication, which may include an
analgesic, a barbiturate, or a tranquilizer may be
administered prior to the examination. Prior to the administration of the contrast agent,
patients should be well hydrated and a preliminary
radiograph taken. The patient should be placed on a
tilt table, semi-erect (30��to 60��). The usual dose per intravenous injection may range
from 50 to 100 mL; the usual total dose per extremity
ranges from 100 to 300 mL. The dose for children
should be reduced in proportion to body weight. The
dose may be given as a bolus injection or by steady
drip infusion. Radiographs are taken at the start of
injection/infusion and periodically thereafter at the
discretion of the radiologist. Following the procedure, the contrast agent may be
removed from the venous system by flushing with
either Dextrose Injection USP 5% or Sodium Chloride
Injection USP 0.9%, or by leg massage and/or leg
elevation.
|
dailymed-instance:descripti... |
Reno-DIP (Diatrizoate Meglumine Injection USP
30%) is a radiopaque contrast agent supplied as a
sterile, aqueous solution for intravenous use, in
300 mL bottles. Each mL provides 300 mg diatrizoate
meglumine; at manufacture, 0.4 mg edetate disodium
sequestering agent is added per mL. The pH has
been adjusted between 6.0 and 7.7 with meglumine
and diatrizoic acid. Each mL of solution also contains
approximately 0.049 mg (0.002 mEq) sodium and
141 mg organically bound iodine.
|
dailymed-instance:clinicalP... |
Following intravenous administration, diatrizoate
meglumine is rapidly transported through the
blood-stream to the kidneys and is excreted
unchanged in the urine by glomerular filtration. When
urinary tract obstruction is severe enough to block
glomerular filtration, the agent appears to be excreted
by the tubular epithelium. Diuresis commonly occurs, due primarily to the
osmotic effects of the contrast agent.<br/>Drip Infusion Pyelography: When a large volume of the contrast agent is
administered in dilute form by intravenous drip
infusion, the nephrographic phase of renal excretion
is enhanced, and a dense, sustained nephrogram is
usually obtained. Following drip infusion of the contrast agent, the
upper and lower urinary tract is opacified.
Anatomically complete pyelograms and voiding
cystograms may be obtained, and the entire course
of the ureter may be seen in a single film. Filling
defects may be visualized and the site of an
obstruction may be clearly localized. Renal accumulation is sufficiently rapid that optimal
opacification of the kidney normally is reached by the
time the infusion is completed, while filling of the
collecting system is maximal within 20 or 30 minutes
after the start of the infusion. Impairment of renal
function commonly delays accumulation and
excretion of the contrast agent, so that opacification
may be delayed until three or more hours after the
infusion; with severe impairment adequate opacification
may not occur. Because transport of the contrast agent is slowed by
renal dysfunction, the ischemic kidney of renal
vascular hypertension may be distinguished from the
normal kidney. Renal ischemia produces a
nephrogram which is slower to appear, less dense,
and sustained for a markedly prolonged period of
time.<br/>Computed Tomography: Reno-DIP enhances computed tomographic brain
scanning through augmentation of radiographic
efficiency. The degree of enhancement of visualization
of tissue density is directly related to the iodine
content in an administered dose; peak iodine blood
levels occur immediately following rapid infusion of
the dose. These levels fall rapidly within five to ten
minutes. This can be accounted for by the dilution in
the vascular and extracellular fluid compartments
which causes an initial sharp fall in plasma
concentration. Equilibration with the extracellular
compartments is reached in about ten minutes;
thereafter, the fall becomes exponential. Maximum
contrast enhancement frequently occurs after peak
blood iodine levels are reached. The delay in
maximum contrast enhancement can range from five
to forty minutes, depending on the peak iodine levels
achieved and the cell type of the lesion. This lag
suggests that radiographic contrast enhancement is
at least in part dependent on the accumulation of
iodine within the lesion and outside the blood pool,
although the mechanism by which this occurs is not
clear. The radiographic enhancement of nontumoral
lesions, such as arteriovenous malformations and
aneurysms is probably dependent on the iodine
content of the circulating blood pool. In brain scanning, Reno-DIP (Diatrizoate Meglumine
Injection USP 30%) does not accumulate in normal
brain tissue due to the presence of the���blood-brain���barrier. The increase in X-ray absorption in normal
brain is due to the presence of contrast agent within
the blood pool. A break in the blood-brain barrier
such as occurs in malignant tumors of the brain
allows the accumulation of the contrast medium
within the interstitial tumor tissue. Adjacent normal
brain tissue does not contain the contrast medium. In nonneural tissues (during computed tomography
of the body), diatrizoate diffuses rapidly from the
vascular into the extravascular space. Increase in
X-ray absorption is related to blood flow,
concentration of the contrast medium, and extraction
of the contrast medium by interstitial tumor tissue
since no barrier exists. Contrast enhancement is thus
due to the relative differences in extravascular
diffusion between normal and abnormal tissue, quite
different from that in the brain. The pharmacokinetics of diatrizoate in both normal
and abnormal tissue have been shown to be variable.
Contrast enhancement appears to be greatest soon
after administration of the contrast medium, and
following intra-arterial rather than intravenous
administration. Thus, greatest enhancement can be
detected by a series of consecutive two- to
three-second scans performed just after injection
(within 30 to 90 seconds), i.e., dynamic computed
tomographic scanning.<br/>Lower Extremity Venography: Following intravenous injection of Reno-DIP
(Diatrizoate Meglumine Injection USP 30%) into a
suitable plantar vein, the agent opacifies those
vessels into which it is distributed, permitting
visualization of deep and superficial veins in the
lower extremities until hemodilution occurs.
|
dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
Reno-DIP is contraindicated for use in intrathecal
procedures. This preparation is contraindicated in patients with a
hypersensitivity to salts of diatrizoic acid. The administration of diatrizoate meglumine is
contraindicated in patients with anuria.
|
dailymed-instance:supply |
Reno-DIP (Diatrizoate Meglumine Injection USP
30%) is available in packages of 10 single dose
300 mL bottles (NDC 0270-0809-75). An excess
volume (1 mL) is available in each container for
sensitivity testing.<br/>Storage: The preparation should be protected from strong
light and stored at 20-25��C (68-77��F) [See USP].
|
dailymed-instance:boxedWarn... |
NOT FOR INTRATHECAL USE
|
dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... | |
dailymed-instance:precautio... |
Diagnostic procedures which involve the use of
radiopaque contrast agents should be carried out
under the direction of personnel with the prerequisite
training and with a thorough knowledge of the
particular procedure to be performed (see ADVERSE
REACTIONS). Severe, life-threatening reactions suggest
hypersensitivity to the radiopaque agent, which has
prompted the use of several pretesting methods,
none of which can be relied upon to predict severe
reactions. Many authorities question the value of any
pretest. A history of bronchial asthma or allergy, a
family history of allergy, or a previous reaction to a
contrast agent warrant special attention. Such a
history, by suggesting histamine sensitivity and a
consequent proneness to reactions, may be more
accurate than pretesting in predicting the likelihood
of a reaction, although not necessarily the severity or
type of reaction in the individual case. The sensitivity test most often performed is the slow
injection of 0.5 to 1 mL of the radiopaque medium,
administered intravenously, prior to injection of the
full diagnostic dose. It should be noted that the
absence of a reaction to the test dose does not
preclude the possibility of a reaction to the full
diagnostic dose. If the test dose causes an untoward
response of any kind, the necessity for continuing
with the examination should be carefully reevaluated
and, if it is deemed essential, the examination should
be conducted with all possible caution. In rare
instances reactions to the test dose itself may be
extremely severe; therefore, close observation of the
patient, and facilities for emergency treatment appear
indicated. The recommended rate of infusion should not be
exceeded. Renal toxicity has been reported in a few patients
with liver dysfunction who were given oral
cholecystographic agents followed by urographic
agents. Diagnostic infusion studies should therefore
be postponed in any patient with a known or
suspected hepatic or biliary disorder who has
recently taken a cholecystographic contrast agent. The diuretic effect of the drip infusion procedure may
hinder an assessment of residual urine in the bladder. Consideration must be given to the functional ability
of the kidneys before injecting diatrizoate meglumine.
Adequate visualization may be difficult or impossible
to attain in uremic patients or others with severely
impaired renal function. Acute renal failure has been reported with the use of
contrast agents in patients with diabetic nephropathy
and susceptible nondiabetic patients (often elderly
with preexisting renal disease). Contrast agents may interfere with some chemical
determinations made on urine specimens; therefore,
urine should be collected before administration of the
contrast media or two or more days afterwards. Caution should be exercised during lower extremity
venography when thrombosis, phlebitis, total venous
system obstruction, severe ischemia, or local
infection is suspected. Extreme caution during
injection of the agent is needed to avoid extravasation
and fluoroscopy is recommended, particularly in
patients with severe arterial or venous disease.<br/>Usage In Pregnancy: The safety of diatrizoate meglumine for use during
pregnancy has not been established; therefore, it
should be used in pregnant patients only when, in the
judgement of the physician, its use is deemed
essential to the welfare of the patient.
|
dailymed-instance:genericMe... |
diatrizoate meglumine
|
dailymed-instance:fullName |
Reno-Dip (Injection, Solution)
|
dailymed-instance:adverseRe... |
Adverse reactions accompanying the use of
iodine-containing intravascular contrast agents are
usually mild and transient although severe and
life-threatening reactions, including fatalities, have
occurred. Because of the possibility of severe
reactions to the procedure and/or the radiopaque
medium, appropriate emergency facilities and
well-trained personnel should be available to treat
both conditions. Emergency facilities and personnel
should remain available for 30 to 60 minutes
following the procedure since severe delayed
reactions have been known to occur. Nausea, vomiting, flushing, or a generalized feeling of
warmth are the reactions most frequently
encountered with intravenous administration of
contrast agents. Such symptoms as chills, fever,
sweating, headache, dizziness, pallor, weakness,
severe retching and choking, wheezing, a rise or fall
in blood pressure, ventricular fibrillation, cardiac
arrest, facial or conjunctival petechiae, urticaria,pruritus, rash, and other eruptions, edema, cramps,
tremors, itching, sneezing, lacrimation, etc., may
occur. Antihistaminic agents may be of benefit; rarely
such reactions may be severe enough to require
discontinuation of dosage. Pulmonary edema, spasm,
seizures, hemiparesis, syncope, and impairment of
vision have also occurred. Neutropenia may also
occur. Severe reactions which may require emergency
measures may take the form of a cardiovascular
reaction characterized by peripheral vasodilatation
with resultant hypotension and reflex tachycardia,
apnea, dyspnea, agitation, and confusion and
cyanosis progressing to unconsciousness. Or, the
histamine-liberating effect of these compounds may
induce an allergic-like reaction which may range in
severity from rhinitis or angioneurotic edema to
laryngeal or bronchial spasm or anaphylactoid shock. Temporary renal shutdown or other nephropathy may
occur. Although local tissue tolerance to diatrizoate
meglumine is usually good, intravenous injection of
the medium in a more concentrated formulation has
produced a few instances of a burning or stingingsensation or numbness and of venospasm or venous
pain, and partial collapse of the injected vein. Although not reported as resulting following lower
extremity venography with diatrizoate meglumine,
conditions such as thrombophlebitis, and the rare
possibility of gangrene, should be considered as
potential adverse reactions.
|
dailymed-instance:warning |
Severe Adverse Events���Inadvertent Intrathecal
Administration: Serious adverse reactions have been reported due to
the inadvertent intrathecal administration of iodinated
contrast media that are not indicated for intrathecal
use. These serious adverse reactions include: death,
convulsions, cerebral hemorrhage, coma, paralysis,
arachnoiditis, acute renal failure, cardiac arrest,
seizures, rhabdomyolysis, hyperthermia, and brain
edema. Special attention must be given to insure that
this drug product is not inadvertently administered
intrathecally. The possibility exists for inadvertent administration
into the intrathecal space during epidural
administrations. Therefore, epidural administration
procedures, such as pain management catheter
placement, should not be performed with use of this
product.<br/>General: A definite risk exists in the use of intravascular
contrast agents in patients who are known to have
multiple myeloma. In such instances there has
been anuria resulting in progressive uremia, renal
failure and eventually death. Although neither the
contrast agent nor dehydration has separately
proved to be the cause of anuria in myeloma, it has
been speculated that the combination of both may
be the causative factor. The risk in myelomatous
patients is not a contraindication to the procedures;
however, partial dehydration in the preparation of
these patients for the examination is not
recommended since this may predispose to the
precipitation of myeloma protein in the renal
tubules. No form of therapy, including dialysis, has
been successful in reversing this effect. Myeloma,
which occurs most commonly in persons over age
40, should be considered before intravascular
administration of a contrast agent. Administration of radiopaque materials to patients
known or suspected to have pheochromocytoma
should be performed with extreme caution. If, in the
opinion of the physician, the possible benefits of
such procedures outweigh the considered risks, the
procedures may be performed; however, the amount
of radiopaque medium injected should be kept to an
absolute minimum. The blood pressure should be
assessed throughout the procedure and measures for
treatment of a hypertensive crisis should be available. Contrast media have been shown to promote the
phenomenon of sickling in individuals who are
homozygous for sickle cell disease when the material
is injected intravenously or intra-arterially. Diatrizoate meglumine should be used with extreme
caution in patients with severe concomitant hepatic
and renal disease, and those with severe
hypertension or congestive heart failure. Since iodine-containing contrast agents may alter the
results of thyroid function tests dependent on iodine
estimation, such tests, if indicated, should be
performed prior to the administration of this
preparation. A history of sensitivity to iodine per se or to other
contrast media is not an absolute contraindication to
the use of diatrizoate meglumine, but calls for
extreme caution in administration. In patients with subarachnoid hemorrhage, a rare
association between contrast administration and
clinical deterioration, including convulsions and
death, has been reported; therefore, administration of
intravascular iodinated ionic contrast media in these
patients should be undertaken with caution.
|
dailymed-instance:indicatio... |
Drip Infusion Pyelography: Reno-DIP is indicated for use in those patients in
whom routine pyelography would not be expected to
be, or has not been, satisfactory for diagnosis. It is
not intended to replace retrograde pyelography where
this procedure is indicated.<br/>Computed Tomography: Reno-DIP (Diatrizoate Meglumine Injection USP
30%) is also indicated for radiographic contrast
enhancement in computed tomography (CT) of the
brain and body. Contrast enhancement may be
advantageous in delineating or ruling out disease in
suspicious areas which may otherwise not have been
satisfactorily visualized.<br/>Brain Tumors: Reno-DIP may be useful to demonstrate the presence
and extent of certain malignancies such as: gliomas
including malignant gliomas, glioblastomas,
astrocytomas, oligodendrogliomas and gangliomas;
ependymomas; medulloblastomas; meningiomas;
neuromas; pinealomas; pituitary adenomas;
craniopharyngiomas; germinomas; and metastatic
lesions. The usefulness of contrast enhancement for the
investigation of the retrobulbar space and in cases of
low grade or infiltrative glioma has not been
demonstrated. In cases where lesions have calcified,
there is less likelihood of enhancement. Following
therapy, tumors may show decreased or no
enhancement.<br/>Non-Neoplastic Conditions of The Brain: The use of Reno-DIP may be beneficial in the
enhancement of images of lesions not due to
neoplasms. Cerebral infarctions of recent onset may
be better visualized with the contrast enhancement,
while some infarctions are obscured if a contrast
medium is used. The use of Reno-DIP (Diatrizoate
Meglumine Injection USP 30%) improved the
contrast enhancement in approximately 60 percent of
cerebral infarctions studied from one week to four
weeks from the onset of symptoms. Sites of active infection also will produce contrast
enhancement following contrast medium
administration. Arteriovenous malformations and aneurysms will
show contrast enhancement. In the case of these
vascular lesions, the enhancement is probably
dependent on the iodine content of the circulating
blood pool. Hematomas and intraparenchymal bleeders seldom
demonstrate any contrast enhancement. However, in
cases of intraparenchymal clot, for which there is no
obvious clinical explanation, contrast medium
administration may be helpful in ruling out the
possibility of associated arteriovenous malformation. The opacification of the inferior vermis following
contrast medium administration has resulted in
false-positive diagnoses in a number of normal
studies.<br/>Body Scanning: Reno-DIP may be used for enhancement of
computed tomographic scans performed for
detection and evaluation of lesions in the liver,
pancreas, kidneys, aorta, mediastinum, abdominal
cavity, pelvis and retroperitoneal space. Enhancement of computed tomography with
Reno-DIP may be of benefit in establishing diagnoses
of certain lesions in these sites with greater
assurance than is possible with CT alone, and in
supplying additional features of the lesions (e.g.,
hepatic abscess delineation prior to percutaneous
drainage). In other cases, the contrast agent may
allow visualization of lesions not seen with CT alone
(e.g., tumor extension), or may help to define
suspicious lesions seen with unenhanced CT (e.g.,
pancreatic cyst). Contrast enhancement appears to be greatest within
60-90 seconds after bolus administration of the
contrast agent. Therefore, utilization of a continuous
scanning technique (���dynamic CT scanning���) may
improve enhancement and diagnostic assessment of
tumor and other lesions such as an abscess,
occasionally revealing unsuspected or more extensive
disease. For example, a cyst may be distinguished
from a vascularized solid lesion when pre-contrast
and enhanced scans are compared; the non-perfused
mass shows unchanged X-ray absorption (CT
number). A vascularized lesion is characterized by an
increase in CT number in the few minutes after a
bolus of intravascular contrast agent; it may be
malignant, benign or normal tissue, but would
probably not be a cyst, hematoma, or other
nonvascular lesion. Because unenhanced scanning may provide adequate
diagnostic information in the individual patient, the
decision to employ contrast enhancement, which
may be associated with risk and increased radiation
exposure, should be based upon a careful evaluation
of clinical, other radiological, and unenhanced CT
findings.<br/>Lower Extremity Venography: Reno-DIP (Diatrizoate Meglumine Injection USP
30%) is also indicated for lower extremity
venography.
|
dailymed-instance:represent... | |
dailymed-instance:routeOfAd... | |
dailymed-instance:name |
Reno-Dip
|